The primary objective is to study the value of serum procalcitonin as a predictive marker for severe bacterial infection in febrile infants.

2200 febrile infants aged less than 3 months will prospectively be included. All infants will have a measure of Procalcitonin concentrations. Comparison of the mean value of Procalcitonin concentration in infants with and without serious Bacterial infection.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Area under the ROC curve of the serum Procalcitonin concentration in the diagnosis of serious bacterial infections [ Time Frame: At the day of emergency consultation for fever ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Diagnostic value (sensibility and specificity) of clinical examination versus procalcitonin [ Time Frame: At the day of emergency consultation for fever ] [ Designated as safety issue: No ]

Diagnostic value (sensibility and specificity) of complete blood count versus procalcitonin [ Time Frame: At the day of emergency consultation for fever ] [ Designated as safety issue: No ]

Diagnostic value (sensibility and specificity) of CRP versus procalcitonin [ Time Frame: At the day of emergency consultation for fever ] [ Designated as safety issue: No ]

Serious bacterial infections are often difficult to detect in infant with fever without source. Procalcitonin is a better blood marker of infection than White blood cell count and possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription. Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in children 1 to 3 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate.

Eligibility

Ages Eligible for Study:

up to 3 Months (Child)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

children 7 days older to 3 month older with fever

Criteria

Inclusion Criteria:

Infant older than 7 days old and less than 3 months old.

Fever (defined by a rectal temperature greater than or equal to 38°C)

Emergency consultation

Exclusion Criteria:

Infants with a previously identified immunodeficiency or chronic disease,

Antibiotic treatment within the previous 48 hours

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00800488